A small part of larger revisions to European pharmaceutical regulatory and marketing legislation may allow pharma companies to develop open dialogues with some European consumers. Historically, product information in Europe was directed only to physicians; consumers could access that material only if it was bundled with all available treatment options as part of an unbranded disease-awareness effort.
Changes underway stem from a European Commission review of the centralized authorization procedure implemented in 1995. The current proposal aims to give patients access to information about products marketed in their countries in their own languages. In addition, the proposed changes set up a system for managing DTC communications instead of surrendering control to countries, such as Latin America, Brazil, Canada, and the United States, that allow companies to post branded messages on the internet for all to see.
"The European Commission recognizes that there is significant value in accessing more information and massive value in accessing the right information," says Michael Edwards, a senior manager of pharmaceuticals and medical products at Accenture. "It wants to take steps in making the provision of information more consistent and supportive of patients making treatment decisions."The commission approved a five-year pilot study that allows companies to provide branded information through brochures or on the internet about AIDS, diabetes, and asthma treatments only. I.C. Dodds-Smith, an attorney with the United Kingdom's Cameron McKenna, says the reasons for singling out those particular conditions remain obscure and that patient groups are complaining that the selection is arbitrary.
The pilot study also sets up a reviewer role for the European Agency for the Evaluation of Medicinal Products (EMEA) that is similar to FDA's Division of Drug Marketing, Advertising, and Communications.
"We don't think this will work because, frankly, EMEA is not FDA. It will become a very cumbersome process," says Christophe de Callatay, communications manager for the European Federation of Pharmaceutical Industries and Associations (EFPIA). "When the commission proposal came out, consumer groups and the UK's media presented it as pushed by the pharma industry. That isn't the case."
EFPIA and consumer groups say they simply want companies to fulfill patients' and healthcare professionals' requests for more information rather than to offer it. According to Mark Chataway, Edelman Health's European chairman, the commission modified its proposal to echo that sentiment in media interviews and in EC member Erkki Liikanen's press conference speech reviewing the organizations' proposals.
The pilot will continue to take shape as the report goes through the European Union legislative process. Adoption remains unlikely before 2003. Chataway says, to speed the process, the commission floated the idea of passing the legislation under the Lisbon Accord on the Open Society, an EU government initiative that expands Europe's capabilities in information technology.
Despite the push for better informed patients, Europe is not moving toward the US style of blanket DTC campaigns. Rather, EU countries' adoption of different technologies than those present in the United States will shape a more tailored approach to disseminating consumerinformation.
"Big TV and print advertising campaigns, an essential part of American DTC communications, is not applicable to Europeans," Chataway says. "By next year, most of Western Europe will be using interactive digital TV-satellite television hooked up to a keyboard so viewers can choose interactively what information they want. That same interactivity and customization will be available on broadband mobile telephones in Europe starting this year."